The Recall Desk
HighFDA (Devices)·Z-0172-2023·Announced 2022-11-09

BD Trucount Tubes Recalled Due to Partial Label Detachment Causing Operational Failures

Becton Dickinson is recalling BD Trucount Tubes due to partial label detachment that can cause tubes to stick together in pouches or fail when used with automated loaders. No illnesses have been reported.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II FDA medical device for blood testing where label detachment can cause tubes to stick together or automation errors, creating a risk of improper test operation. No illnesses or injuries have been reported, but the defect qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

BD Trucount Tubes (Catalog Number 663028) are laboratory devices used to determine the absolute count of white blood cells in blood samples. They are designed for use with BD Tritest reagents and flow cytometers, including use with the BD FACS Loader automated system.

The tubes are being recalled due to partial label detachment. Investigation by the manufacturer found that an adhesive change made by a supplier caused labels to detach from the tubes. When labels detach, tubes can become stuck together in their pouches or cause automation errors when used with the automated loader for the wash assistant.

Becton Dickinson and Company, BD Biosciences initiated the recall which affects 11,709 units distributed in multiple U.S. states and internationally. The recalled lot numbers are 2031238, 2063994, 2095615, 2145791, 2221697, and 2237045.

The recalled product

Product
BD Trucount Tubes (Cat. No. 663028), used for determining absolute counts of leukocytes in blood. BD Trucount Tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount Tubes can be used with the B
Manufacturer
Becton, Dickinson and Company, BD Biosciences
Category
Medical Device — Laboratory / Blood Testing
Hazard

Distribution

Distributed in 43 states:

Part of a larger recall action

This product is one of 3 recalled by Becton, Dickinson and Company, BD Biosciences under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Becton, Dickinson and Company, BD Biosciences

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Same hazard · label detachment

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